510(k) K905199

PACSNET RESEARCH TOOLKIT by Siemens Gammasonics, Inc. — Product Code LMD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 14, 1991
Date Received: November 20, 1990
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Digital Image Communications, Radiological
Device Class: Class I
Regulation Number: 892.2020
Review Panel: RA
Submission Type

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.

Other clearances by Siemens Gammasonics, Inc.

K934766 — CARBON FIBER PALLET (February 18, 1994)
K933664 — POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) (December 15, 1993)
K933256 — FAN BEAM COLLIMATOR (October 29, 1993)
K920319 — SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI (October 20, 1992)
K923582 — SIENET CAMERA SERVER (October 14, 1992)
K922373 — MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM (August 17, 1992)
K922372 — MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM (August 17, 1992)
K920310 — SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE (March 30, 1992)
K920309 — SIENET DIAGNOSTIC REPORTING CONSOLE (March 20, 1992)
K914313 — HICOR (November 27, 1991)

Other clearances for product code LMD

K994329 — IIVS INTEGRATED IMAGE VIEWING STATION (May 26, 2000)
K992698 — STENTOR, PAGEVIEW (October 25, 1999)
K992426 — RAYPAX WEB CLINICAL SYSTEM (October 13, 1999)
K992352 — ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 (September 29, 1999)
K991537 — SAMSUNG RAYPAX SYSTEM (July 6, 1999)
K984000 — STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM (January 12, 1999)
K974707 — IMAGEQUEST (July 31, 1998)
K981053 — KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW (June 18, 1998)
K980918 — JPACS (June 3, 1998)
K974882 — DOWNSCAN LT (May 22, 1998)